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Uri-Trak 120 Analyzer Refurbished

STANBIO LABORATORY, L.P. · Model G1200-001R · UDI-DI 00657498001981

KQO Prescription

510(k) clearances

1,086

Adverse events (1 deaths)

Recalls

Facilities

Description

The Uri-Trak™ 120 Urine Analyzer is intended for use in conjunction with Stanbio Uri-Chek™ and Uri-Con™ 10 Urinalysis Reagent Strips for the semi-quantitative detection of the following analytes in urine: Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific Gravity, Blood, pH, Protein, Urobilinogen, and Leukocytes, as well as the qualitative detection of Nitrite. The instrument is intended for professional, in vitro diagnostic use only.

Recalls

Date	Firm	Reason
2023-04-05	Beckman Coulter, Inc.	Beckman Coulter has become aware of an intermittent issue in which the optional flag Previous Sample Had Sperm was enabled but not displayed so that a carryover event could have be
2023-04-05	Beckman Coulter, Inc.	Beckman Coulter has become aware of an intermittent issue in which the optional flag "Previous Sample Had Sperm" was enabled but not displayed so that a carryover event could have
2023-04-05	Beckman Coulter, Inc.	Beckman Coulter has become aware of an intermittent issue in which the optional flag "Previous Sample Had Sperm" was enabled but not displayed so that a carryover event could have
2023-04-05	Beckman Coulter, Inc.	Beckman Coulter has become aware of an intermittent issue in which the optional flag "Previous Sample Had Sperm" was enabled but not displayed so that a carryover event could have
2021-10-18	Roche Diagnostics Operations, Inc.	A potential risk for false negative nitrite results exists when endogenous creatinine levels are 15,000 mg/L and above. No interference of Nitrite results was observed at creatinin
2020-03-30	Beckman Coulter Inc.	A defect in the SATA power adapter cable within the instrument s computer has the potential risk for an electrical short that may lead to the following outcomes: charring and/or me
2020-03-30	Beckman Coulter Inc.	A defect in the SATA power adapter cable within the instruments computer has the potential risk for an electrical short that may lead to the following outcomes: charring and/or mel
2020-02-17	Beckman Coulter, Inc.	The Leukocyte and Compensation pads were switched on some vials of lot number 7212269M of the iChem VELOCITY Strips.
2020-01-21	Sysmex America, Inc.	When excessive amounts of urine spills on the rack transport track and reaches the electrical components of the CV-11 conveyor, there is a potential for smoke and/or sparks which
2019-11-07	Beckman Coulter Inc.	Beckman Coulter has become aware of an issue affecting Specific Gravity chemistry settings for the iChemVELOCITY Urine Chemistry System that prevents the trigger of a chemistry sys

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.